PPI’s Bijan Elahi MSEE, BS AeroE presented a webinar, “Insights into Risk Management for Medical Devices” to members of INCOSE’s Biomedical Working Group on Tuesday, 14 November 2018. The webinar will be available on the Group’s website, and subsequently on YouTube.
Synopsys: “The word “risk” has many meanings, depending on the discipline within which it is applied. For Medical Devices, risk is about the probability of causing harm to humans. ISO 14971 is the central standard that governs risk management for medical devices. This standard was first released in 2000 and offers a framework for the management of safety risks of medical devices. In this presentation, we will talk about the requirements of ISO 14971, why we do risk management, and what the benefits and main challenges of performing risk management are.”
This webinar is potentially available to other societies having a direct interest in the development of medical devices – please contact PPI to engage in discussion if you are interested.